PIP: MHRA Raises Questions About Responsibility Of “Member States”

There was an inevitability about it, and UK competent authority the MHRA has let its guard slip just a bit in its letter responding to a fairly damning Financial Times article. The response can be found here and in it, the emost interesting bit comes at the end, where it appears to point the finger at “other” competent authorities, as follows:

“Medical device regulation in Europe is based on full mutual recognition of the CE mark. The PIP incident raises questions about the responsibility Member States (and their taxpayers) should carry for policing manufacturers and for monitoring clinical outcomes of surgical procedures in the private sector. These issues will be examined in the various reviews in progress in the UK and in the European Commission, including the planned revision of the Medical Devices Directives for which the Commission is due to bring forward proposals this summer.”

It might not be quite as spiky as it sounds, but there’s definitely no admission in the letter that MHRA itself was to blame.

Source: MHRA